Manufacture Smarter Blog

Not All Food Failures Are Hazardous, but All Are Costly

8/10/2018 By: John Spillson The idea of Failure Mode and Effects Analysis (FMEA) was formally introduced to the world by the military shortly after WWII. Due to failures in munitions during the campaign, this methodology was developed to identify and eliminate critical defects in production. In the 1950s, FMEAs began to be applied in aerospace and rocket development to achieve high levels of quality and safety. Another significant push for failure prevention came in the 1960s with the increase in space exploration as countries around the world raced to put a man on the moon.

Achieving Competency in Quality - Manufacturing's Got Talent!

2/2/2018 By: Andy Nichols Competency is all around us. It pervades our lives. We see competency on television, for example, in “America’s Got Talent.” Talented people, regardless of their age, gender or social background, performing all manner of stage acts that wow the show’s judges and viewers. We often ask ourselves, “How did they do that?” We see competency in Quality as well. ISO 9001 includes a requirement for an organization’s people, specifically those involved in the Quality Management System, to be competent in their work responsibilities.

Quality Manuals – QMS “Quick-start” Guide?

11/3/2017 By: Andy Nichols One of the first things that comes to mind when describing Quality Management Systems and “ISO 9000” is documentation, which often includes a Quality Manual. The background to Quality Management Systems started with big procurement organizations such as government agencies and Fortune 500 companies making Quality Systems a contractual requirement. Frequently, these requirements included the need for a document, often referred to as a “Quality Manual,” a “Quality Plan” or similar.

10 Things to Ask Your Certification Body Auditor – Before Your ISO 9001:2015 Audit

9/29/2017 The latest version of ISO 9001 was published in September of 2015 and is considered to be a significant departure from the previous version because: There’s no reference to a Quality Manual No Documented Procedures are required The use of Work Instructions isn’t mentioned A Management Representative isn’t required The standard mentions “risk and opportunity” The terminology of controlled documents and records has been replaced by “documented information” A new requirement, the “Context of the Organization,” has been added.

A Year to Go...

9/15/2017 If your organization is certified to ISO 9001:2008 (or ISO/TS 16949 or AS9100C) you have approximately 365 days left to upgrade your Quality Management System (QMS) and have your Registrar audit it. In fact, you should aim to be done and have your certificate in hand by the end of August 2018 at the latest. Meeting the Deadline To be exact, ISO 9001:2008 expires at midnight on September 14, 2018. A question I am often asked is: What if an organization wasn’t able to prepare and successfully complete their audit? The simple answer is that the Registrar would request their certificate be returned, the organization would not be able to post their certificate on their website (for example) and they would not be able to use the Registrar’s logos, etc.

ISO 9001:2015 Internal Audits

6/30/2017 “Is the Process Approach to Audits Just a Myth?” By: Andy Nichols Since ISO 9001:2000, it’s become increasingly common to consider that an organization’s Internal Quality Audits be performed using the so-called “Process Approach.” At the time of publication, that particular version of the International Standard for Management Systems contained no description of what the process approach was. The recently introduced 2015 version makes the “Process Approach” a lot clearer by describing what is envisaged, in section 0.

Risk in ISO 9001:2015 Transition?

6/2/2017 By: Dale Wicker In the ISO 9001:2015 standard there are two basic terms encompassing risk: risk-based thinking and the compound term risk and opportunities. Risk-based thinking is intended to be the system or approach an organization takes when considering risks and opportunities. These risk and opportunities are only those that may affect the organization’s ability to enhance customer satisfaction and consistently meet customer requirements, and, as applicable, statutory and regulatory requirements.

QMS True North

11/18/2016 When navigating by map and compass, it is important to be aware of magnetic declination. The magnetic north is not located at the North Pole, so more than likely, your compass is not truly pointing north. You need to adjust your compass reading and account for the difference to find True North. Knowing where true north is can make a big difference in getting to where you want to be. True North in Lean Manufacturing In the world of Lean Manufacturing, True North is also important.  As you start out your lean journey, you will begin with a Value Stream Map of your current state.